Implementation ledger
A chronological record of material rule, standards, company, product, operating, and research changes. Each entry preserves the source class, effective date, market consequence, and affected capability areas.
EMA releases minor human and veterinary MAA eAF 1.28 versions
EMA says the July 14 files include bug fixes and updated release notes. The record should be read with the procedure-specific mandatory-use dates on the same official page.
FDA updates eCTD v4.0 regional and conformance materials
FDA's version history records changes to the regional controlled-vocabulary package, technical conformance guide, and transmission specifications and adds forward-compatibility XML samples. This is a standards-package update, not evidence that every RIM or publishing product supports the new materials.
EMA documents release of the public PMS API beta
EMA says the beta provides external access to selected structured, machine-readable medicinal-product data and is expected to evolve through an experience period ending in early 2027.
First four EUDAMED modules become mandatory
The European Commission says mandatory use begins for Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance. The notice establishes module status, not a certification of any commercial integration.
FDA issues final Computer Software Assurance guidance
The February 2026 guidance recommends a risk-based approach to establish confidence in software used for medical-device production or quality management and supersedes the September 2025 document.
FDA Quality Management System Regulation takes effect
FDA says amended 21 CFR Part 820 now incorporates ISO 13485:2016 by reference, is titled QMSR, and is used with a new device inspection process that replaces QSIT.
Revised EU Variations Guidelines begin to apply
EMA says the new guidelines apply from January 15, 2026 and describes different transition rules for Type IA versus Type IB and II variations.
EU consultation closes on draft GMP Chapter 4, Annex 11, and new Annex 22
The consultation record covers draft updates for documentation and computerised systems and a proposed artificial-intelligence annex. It is closed, but the draft text is not an operative final requirement.